A Study to Assess the Safety of TPM502 in Adults With Celiac Disease

A Double-blind, Randomized, Placebo-controlled, Phase 2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamic (PD) Effects of Two Infusions of Escalating Doses of TPM502 in Adults Diagnosed With Celiac Disease

The goal of this clinical trial is to learn about the safety and the pharmacodynamic (PD) effects of TPM502 in adults with celiac disease. The main questions it aims to answer are:

• if TPM502 is safe and well tolerated
• if TPM502 can induce modifications in parameters indicating that it may induce tolerance to gluten

Participants will:

• undergo 1-day gluten challenge during screening and after administration of TPM502 or placebo.
• receive 2 infusions of TPM502 or placebo, 2 weeks apart

Study Overview

• Status: Completed
• Conditions: Celiac Disease
• Intervention / Treatment: Other: Placebo; Drug: TPM502

Detailed Description

This is a multi center, double-blind, randomized, placebo-controlled Phase 2a study to evaluate the safety, tolerability, and PD effects of two infusions of TPM502 in adult patients diagnosed with CeD.

The patient´s participation in the study comprises 3 phases: screening period, treatment period and follow-up period.

Patients fulfilling the eligibility criteria will be randomized to receive two infusions of TMP502 (or placebo) at the same dose level. Patients will undergo a second GC one week after the second infusion of TPM502.

The study includes 4 cohorts of patients, each cohort will receive escalating doses of TPM502 (or placebo). Upon completion of the 3rd cohort, a lower dose can be investigated, if deemed relevant.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Brisbane, Australia, 4066
    • Wesley Research Institute
• Finland
  • Turku, Finland, FI-20520
    • CRST Oy
• Germany
  • Berlin, Germany, 12200
    • Charite' Hospital
• Netherlands
  • Leiden, Netherlands, 2333 ZA
    • Centre For Human Drug Research
• Norway
  • Oslo, Norway, 0372
    • Oslo University Hospital HF - Rikshospitalet
  • Tromsø, Norway, 9038
    • University Hospital of North-Norway
• Sweden
  • Uppsala, Sweden, 752 37
    • Clinical Trial Consultants, Uppsala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Availability of a documented biopsy-confirmed diagnosis of CeD OR documented tissue transglutaminase >10x ULN and documented positive IgA anti-endomysial antibody (EMA) at time of CeD diagnosis (as per local guidelines)
• Serum anti-tissue transglutaminase 2 immunoglobin A antibodies within normal range (i.e., <15 U/mL) at screening
• Serum IL-2 levels (AUC1-6h) above a pre-defined threshold following the GC at screening
• Patients must have been on GFD for ≥ 6 months
• Patients must have well-controlled CeD, defined as mild or with no ongoing signs or symptoms felt to be related to active CeD, as per investigator's assessment
• HLA-DQ2.5 positive

Exclusion Criteria:

• Known or suspected refractory CeD (refractory CeD type I or II)
• Known intolerable symptoms following previous GCs, as per investigator's assessment
• HLA DQ8 positive
• Any active gastrointestinal disease such as gastroesophageal reflux disease, esophagitis or peptic ulcer, microscopic colitis, or irritable bowel syndrome, which in the opinion of the investigator might interfere with the assessment of the symptoms related to CeD
• Known history of or active Crohn's disease, ulcerative colitis, or ulcerative jejunitis
• Known wheat allergy
• Known hypersensitivity to i.v. iron preparations or any other excipients present in the reconstituted TPM502 or placebo

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: Placebo; Placebo
Experimental: TPM502	Drug: TPM502; TPM502 contains 3 peptides each consisting of two overlapping T cell epitopes that encompass the major gluten epitopes for HLA-DQ2.5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence, severity, causality, and outcomes of treatment-emergent adverse events	throughout the study, on average 43 days

Collaborators and Investigators

• Sponsor: Topas Therapeutics GmbH
• Investigators: Principal Investigator: Knut Lundin, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: tolerance; celiac disease
• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Nutritional and Metabolic Diseases; Celiac Disease
• Other Study ID Numbers: TCeD21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No